UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055630 |
|---|---|
| Receipt number | R000063573 |
| Scientific Title | Exploration of factors associated with intraoperative massive bleeding in surgery using cardiopulmonary bypass |
| Date of disclosure of the study information | 2024/09/26 |
| Last modified on | 2024/09/26 11:07:59 |
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Basic information
Public title
Exploration of factors associated with intraoperative massive bleeding in surgery using cardiopulmonary bypass
Acronym
Exploration of factors associated with intraoperative massive bleeding in surgery using cardiopulmonary bypass
Scientific Title
Exploration of factors associated with intraoperative massive bleeding in surgery using cardiopulmonary bypass
Scientific Title:Acronym
Exploration of factors associated with intraoperative massive bleeding in surgery using cardiopulmonary bypass
Region
| Japan |
Condition
Condition
Surgery using cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Aesthetic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to identify the factors associated with massive bleeding during surgery using cardiopulmonary bypass. If there is insufficient blood supply, blood transfusions must be urgently arranged from outside the hospital in the event of massive bleeding, but if there is too much blood supply, there is a waste of medical resources due to the disposal of blood products. By identifying the factors associated with massive bleeding during surgery using cardiopulmonary bypass, it may be possible to not only improve perioperative safety, but also to make effective use of medical resources.
Basic objectives2
Others
Basic objectives -Others
Investigating risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of massive bleeding
Key secondary outcomes
Amount of blood transfused during surgery (RBC, FFP, Plt)
Use of coagulation factors during surgery
Main postoperative complications related to bleeding
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent heart surgery using a cardiopulmonary bypass at the University of Tsukuba Hospital between April 1, 2012 and March 31, 2023
Key exclusion criteria
1. Age < 18 years
2. Patients with errors or missing data in the main data
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Translational Research & Development Organization
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
+81-29-853-3914
shimada.kensuke.gu@u.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Shimada |
Organization
University of Tsukuba
Division name
Translational Research & Development Organization
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
TEL
+81-29-853-3914
Homepage URL
shimada.kensuke.gu@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576, Japan
Tel
+81-29-853-3914
shimada.kensuke.gu@u.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the dataset created by the "Large-scale observational study on the quality of perioperative care using perioperative dataset from the University of Tsukuba Hospital (R03-068)".
Management information
Registered date
| 2024 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063573
